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Company Overview of Xcovery LLC
Xcovery LLC, a biopharmaceutical company, develops oncology therapies to target a range of advanced tumors. It offers X-396, a small molecule that inhibits anaplastic lymphoma kinase. The company also develops MET and PI3K/mTOR kinase inhibitors for advanced tumors. Xcovery LLC was founded in 2006 and is based in Palm Beach Gardens, Florida.
11780 U.S. Highway One
Palm Beach Gardens, FL 33408
Founded in 2006
Key Executives for Xcovery LLC
Chief Executive Officer and President
Chief Scientific Officer, Executive Vice President and Director
Vice President of Oncology
Executive Director of Clinical Operations
Compensation as of Fiscal Year 2016.
Xcovery LLC Key Developments
Xcovery Announces Initiation of Phase 3 Trial of X-396 in ALK+ Non-Small Cell Lung Cancer
Jun 29 16
Xcovery announced the initiation of its Phase 3 trial of X-396 in patients with anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC). The eXalt3 trial is an open-label, randomized study designed to evaluate the efficacy and safety of X-396, the company’s lead ALK inhibitor drug candidate, versus crizotinib in over 400 patients with ALK+ NSCLC. The Phase 3 eXalt3 study is an open-label, randomized study that will evaluate the efficacy and safety of the ALK inhibitor X-396 compared to crizotinib in patients with ALK+ NSCLC. The primary efficacy endpoint being measured is progression-free survival (PFS) as assessed by an independent radiology review based on RECIST v. 1.1 criteria. The study will also allow the company to obtain additional pharmacokinetic data on X-396 in select patients and samples for exploratory biomarkers research to be compared against the clinical outcomes. The company expects to enroll approximately 400 patients who have received up to one prior chemotherapy regimen and no prior ALK tyrosine kinase inhibitor (TKI) treatments. The trial is designed so patients either receive a 225 mg daily dose of X-396 or a 250 mg dose twice a day of standard-of-care crizotinib over a 28-day schedule.
Xcovery Announces Results from the Ongoing Phase I/II Clinical Study of its Investigational Tyrosine Kinase Inhibitor (TKI), X-396
Apr 20 16
Xcovery announced that results from the ongoing Phase I/II clinical study of its investigational tyrosine kinase inhibitor (TKI), X-396, in patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) were presented at the American Association for Cancer Research (AACR) Annual Meeting 2016 held in New Orleans, LA. The results presented include data from more patients, responses and safety data for all patients in the Phase I/II “Xalt2” study. Results were presented by Dr. Christine Lovly, MD, PhD, Assistant Professor of Medicine, Division of Hematology-Oncology at the Vanderbilt University School of Medicine, in a poster titled “Phase I/II trial of ensartinib (X-396), a novel anaplastic lymphoma kinase (ALK) inhibitor, in patients with ALK+ non-small cell lung cancer (NSCLC).” Ensartinib is the proposed International Non-Proprietary Name (INN), also referred to as X-396. Phase I/II “Xalt2” Study: The data presented include safety analyses on all patients in the trial (N=63) and efficacy analyses on evaluable patients treated at doses of 200 to 250 mg per day (n=35). The presentation is based on patient information in the database as of March 14, 2016. Patient enrollment in the Xalt2 trial is continuing at a dosage of 225 mg daily. Safety and Tolerability – All Patients Enrolled (N=63): The most common adverse event (AE) related to treatment was rash in 52% of patients, mostly grade 1 or 2. Other commonly reported related AEs were nausea (29%), fatigue (25%), vomiting (24%), and pruritus (21%). No other related AEs were seen at a rate of =20%. The most common related grade 3 or higher AE was rash (11%); no other grade 3 or higher related AE was observed in more than one patient (<2%). Anti-tumor Activity – Evaluable ALK+ NSCLC Patients Treated at 200 to 250 mg Daily (n=35); Objective response rate was 88% (7/8) in ALK-TKI treatment-naïve patients. ALK-TKI treatment-naïve patients have been on treatment up to 30 months, and crizotinib- resistant patients have been on treatment for up to 29 months. In crizotinib-resistant patients that did not receive a prior 2nd generation ALK TKI, 16 of 19 have demonstrated reductions in target lesion dimensions. In patients with target CNS lesions, 5 of 8 have demonstrated reductions in CNS lesion dimension. Responses have been observed in patients who were resistant to both crizotinib and a 2nd generation inhibitor.
Xcovery LLC Presents at 18th Annual BIO CEO & Investor Conference 2016, Feb-09-2016 01:15 PM
Jan 30 16
Xcovery LLC Presents at 18th Annual BIO CEO & Investor Conference 2016, Feb-09-2016 01:15 PM. Venue: The Waldorf Astoria, 301 Park Avenue, New York, New York, United States.
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